Endobronchial valves for emphysema: an individual patient level reanalysis of randomised controlled trials

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Title: Endobronchial valves for emphysema: an individual patient level reanalysis of randomised controlled trials
Authors: Hopkinson, NS
Shah, PL
Davey, C
Item Type: Journal Article
Abstract: Introduction Endobronchial valve placement has potential as a treatment for patients with chronic obstructive pulmonary disease (COPD). However, a robust evidence base will be needed to convince commissioners of healthcare that it is a high-value treatment. We sought to develop the evidence base by performing an individual patient-level analysis of randomised controlled trials in people with heterogeneous emphysema and an absence of collateral ventilation. Methods A literature search (PROSPERO register CRD42016048127) identified two trials meeting these criteria, the BelieVeR-HIFi and STELVIO studies. Anonymised individual patient data were obtained from investigators and analysed. The primary outcome measure was a comparison of change in forced expiratory volume in 1 s (FEV1) from baseline between the treatment and control groups. Secondary end points were change from baseline in 6 min walk distance (6MWD), Medical Research Council dyspnoea score and St George’s Respiratory Questionnaire (SGRQ). Results 114 individuals were treated with 3-month to 6-month follow-up data available for 101 individuals. FEV1 improved by 23.1 (±28.3)% in patients treated with valves with a mean (95% CI) difference in response between groups of 17.8 (26.5, 9.2)% (p<0.0001). Relative to controls valve placement was associated with a fall in residual volume of 0.64 (0.43, 0.86) L (p<0.0001), a 9.5 (3.5, 15.6) unit fall in SGRQ (p=0.0022) and a 64.2 (94.0, 34.5) m increase in 6MWD. There were three deaths in the treatment arm and the pneumothorax rate was 15%. Conclusions These data strengthen the evidence that endobronchial valve treatment can produce clinically meaningful improvements in appropriately selected COPD patients.
Issue Date: 1-Nov-2017
Date of Acceptance: 11-Oct-2017
ISSN: 2052-4439
Publisher: BMJ Publishing Group
Journal / Book Title: BMJ Open Respiratory Research
Volume: 4
Copyright Statement: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: UD99999959
Publication Status: Published
Embargo Date: publication subject to indefinite embargo
Article Number: e000214
Appears in Collections:National Heart and Lung Institute
Airway Disease
Faculty of Medicine

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